Staff Product Transfer Project Engineer

Staff Product Transfer Project EngineerJob Location: Franklin, TN, USA, 37064 Work Model: Hybrid Work Model Details: 3 Days onsite, 2 days remote Shift: 8 AM - 5 PM CST Mon - Fri Employment Type: Temporary Min Hourly Rate($): 55.00 Max Hourly Rate($): 60.00 Required Education: Bachelor's Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering Preferred Education: Master's Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering Required Skills: Strong understanding of biologics manufacturing, upstream and downstream bioprocessing, sterile manufacturing, single-use systems, protein formulation, stability, and analytical methods. Serve as the primary engineering liaison between external manufacturing partners and internal Technical Operations, Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Validation teams.

Staff Product Transfer Project EngineerJob Location: Franklin, TN, USA, 37064 Work Model: Hybrid Work Model Details: 3 Days onsite, 2 days remote Shift: 8 AM - 5 PM CST Mon - Fri Employment Type: Temporary Min Hourly Rate($): 55.00 Max Hourly Rate($): 60.00 Required Education: Bachelor's Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering Preferred Education: Master's Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering Required Skills: Strong understanding of biologics manufacturing, upstream and downstream bioprocessing, sterile manufacturing, single-use systems, protein formulation, stability, and analytical methods. Working knowledge of FDA, EMA, ICH, cGMP requirements, process validation lifecycle, regulatory submissions, and post-approval manufacturing changes. Excellent project management, technical writing, communication, organizational, and stakeholder-influence skills in highly regulated environments. Minimum 4 years supporting technology transfer, manufacturing engineering, process engineering, validation, or scale-up in FDA-regulated cGMP environments. Experience working with Contract Manufacturing Organization (CMOs) and scientific leadership experience in GMP biologics manufacturing are preferred.Responsibilities: Lead end-to-end bioprocess technology transfer activities, including process adaptation, scale-up, equipment qualification, validation, and commercial readiness. Serve as the primary engineering liaison between external manufacturing partners and internal Technical Operations, Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Validation teams. Collaborate with internal cross-functional teams and external partners to lead technical discussions, resolve issues, communicate project status, risks, and recommendations to leadership, and ensure successful execution of transfer activities. Conduct engineering gap assessments and technical risk evaluations using structured methodologies such as FMEA. Support regulatory submissions, Biologics License Application (BLA) supplements, inspection readiness, and technical justifications related to manufacturing transfers. Support analytical test method transfers activities, IQ, OQ, PQ, GMP, non-GMP, engineering, and PPQ campaign execution, including review of protocols, reports, batch records, and technical documentation to ensure compliance with regulatory expectations, quality standards, and project timelines. Manage engineering change strategies, ECOs, and documentation release activities through change control systems. Perform other duties as assigned to support Product Transfer and Technical Operations.